MasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- LNCS TC-I SpO2, Reusable Ear Sensor, >30kg, 3 ft EUDAMEDMasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- LNCS SET Reusable Sensors EUDAMEDMasimoSET LNCS TC-I SpO2 Reusable Ear Sensor FDA UDI
- Model / Reference
- 1895 EUDAMEDFDA UDI
- Description
- MasimoSET LNCS TC-I SpO2 Reusable Ear Sensor FDA UDI
Identifiers
- Catalog Number
- 1895 FDA UDI
- Primary DI / UDI-DI
- 00843997000048 EUDAMEDFDA UDI
- Basic UDI-DI
- 084399700000Z1T1B04V001FY EUDAMED
- Direct Marketing DI
- 00843997000048 EUDAMED
- 510(k) Number
- K051212 FDA UDI
- FDA Product Code
- DPZ FDA UDI
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2710 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Pulse oximeter probe, reusable
MasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor by Masimo Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, reusable.
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Cleared under the same submission
K051212 also covers:
- LNCS SpO2 — MASIMO CORPORATION
- LNCS® DCI® Reusable Starter Kit — MASIMO CORPORATION
- M-LNCS DCI SpO2 Adult Reusable Finger Clip Sensor — MASIMO CORPORATION
- M-LNCS™ DCI-P SpO2 Pediatric/Slender digit Adult Reusable Finger Clip Sensor — MASIMO CORPORATION
- Masimo Forehead Sensor Headbands — MASIMO CORPORATION
- MasimoSET LNCS® DCI-P SpO2 Pediatric/Slender digit Reusable Finger Clip Sensor — MASIMO CORPORATION
- MasimoSET LNCS® DCI® SpO2 Adult Reusable Finger Clip Sensor — MASIMO CORPORATION
- MasimoSET LNCS® YI SpO2 Multisite Reusable Sensor — MASIMO CORPORATION
- MasimoSET® LNCS® DCI-Pv pediatric/slender digit SpO2 reusable sensor — MASIMO CORPORATION
- MasimoSET® LNCS® DCIv adult SpO2 Reusable Sensor — MASIMO CORPORATION
- MasimoSET® LNCS® TF-I SpO2 Reusable Forehead Sensor — MASIMO CORPORATION
- MasimoSET® M-LNCS™ DCI-Pv pediatric/slender digit SpO2 reusable sensor — MASIMO CORPORATION
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (2)
- FDA UDI 56fa1618-f4bf-45b4-aeec-9f7235755560 37 fields · synced Jul 17, 2026
- EUDAMED c155bfea-9785-499a-9967-7ec9ebe27872 61 fields · synced Jul 17, 2026